NCT04208737

Brief Summary

Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units. The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 23, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

December 16, 2019

Last Update Submit

June 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of FRC measurements at beginning and end of anesthesia

    First FRC will be measured after ; the last FRC will be measure bedore the extubation

    within max 5 minutes after the intubation and with max 5 minutes before the extubation

Secondary Outcomes (1)

  • Positive room air test

    in recovery room 30 minutes after operation

Study Arms (2)

control group

NO INTERVENTION

3 FRC measurements will be perforemed, whereby : First measurement; after aneshesia induction and intubation. Second measurement; after pneumoperitoneum Third measurement; end of the operation After the operation,Postoperative Room Air Test (RAT) will be applied.

study group

EXPERIMENTAL

5 FRC measurements will be performed We will apply recruitment maneuver two times to patients with 30cmH2O pressure for 15 seconds . First Recruitment maneuver will be applied after the fşrst measurement of FRC following intubation Second Recuitment maneuver will be applied at the end of operation First FRC measurement after anesthesia induction and intubation. Second FRC measurement after first recruitment maneuver Third FRC measurement; after pneumoperitoneum Fourth FRC measurement before second recruitment maneuver Fifth FRC measurement after second recruitment maneuver and at the end of operation

Procedure: recruitment maneuver

Interventions

30 cmH2O pressure 15 seconds

study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years age 2-no lung disease 3-laparoscopic cholecystectomies surgery

You may not qualify if:

  • \<18 years old
  • \>65 years old
  • denial of patient
  • patients having one of: lung disease, cardiac failure, severe cardiac valvular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University

Istanbul, 34069, Turkey (Türkiye)

Location

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Elif Aygun, MD

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 23, 2019

Study Start

December 23, 2019

Primary Completion

May 1, 2020

Study Completion

June 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations